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Exercise, Creatine and Coenzyme Q10 for Childhood Myositis

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ClinicalTrials.gov Identifier: NCT04286178
Recruitment Status : Recruiting
First Posted : February 26, 2020
Last Update Posted : April 27, 2021
Sponsor:
Information provided by (Responsible Party):
Brian Feldman, The Hospital for Sick Children

Brief Summary:
Children with JDM are weak and get tired because their muscles aren't able to work like healthy muscles. This can make it hard for them to do normal everyday things and can make them less happy about their lives compared to children without the disease. There are two nutritional supplements that help muscles use energy and recover after exercise: creatine and coenzyme Q10. If the muscle has more energy, it may not be as weak and may not feel as tired or sore after exercise. Because of this we want to see if having children with JDM take creatine and coenzyme Q10 can make them stronger and less tired. If this works, we hope it will let them be able to do the things that healthy children can do, and make them feel better about their lives.

Condition or disease Intervention/treatment Phase
Myositis, Juvenile Dietary Supplement: creatine monohydrate Dietary Supplement: ubiquinol Dietary Supplement: glucose tablet Dietary Supplement: gel capsule Behavioral: Exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This study will be a double-blinded, placebo-controlled, randomized, multiple baseline design (MBD) where each subject will be randomly allocated a start time for the active supplements
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Effects of Exercise, Creatine, and Coenzyme Q10 Supplementation on Muscle Function in Children With Myositis
Actual Study Start Date : April 6, 2021
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : March 31, 2023


Arm Intervention/treatment
Experimental: Treatment
patients in this arm will be treated with creatine and coenzyme Q10 supplements
Dietary Supplement: creatine monohydrate
Creatine will be taken at a dose of 150mg/kg/day of creatine base divided into 2 daily doses up to 39.7kg in body weight, after which dosing will be based on body surface area (BSA) at 4.69g/m2/day. Creatine will be administered orally as a chewable tablet provided by BioTechUSA™. Tablets are 2g and contain 0.9g of creatine monohydrate which is equivalent to 0.8g of creatine base.

Dietary Supplement: ubiquinol
Coenzyme Q10 (CoQ10, ubiquinol) will be taken at a dose of 10mg/kg/day divided into 2 daily doses with a daily maximum of 500mg. CoQ10 will be administered orally in 50mg softgels containing 50mg of ubiquinol (Active Q®), provided by Tishcon Corporation.
Other Name: coenzyme Q10

Behavioral: Exercise
Participants will be coached to hit 12,000 steps or 60 "active minutes" per day as logged by a FitBit (FitBit calculates active minutes as activities equivalent to moderate-to-vigorous physical activity (MVPA) done continuously for at least 10 minutes)

Placebo Comparator: Placebo
patients in this arm will be given placebo supplements that look and taste identical to the active supplements
Dietary Supplement: glucose tablet
Creatine placebo will be in the form of a glucose tablet with identical appearance and taste to the active supplement. The number of tablets/day will be determined based on the dose of creatine required for each patient.

Dietary Supplement: gel capsule
Ubiquinol placebo will be in the form of a gel capsule with identical appearance to the active supplement. The number of capsules/day will be determined based on the dose of ubiquinol required for each patient.

Behavioral: Exercise
Participants will be coached to hit 12,000 steps or 60 "active minutes" per day as logged by a FitBit (FitBit calculates active minutes as activities equivalent to moderate-to-vigorous physical activity (MVPA) done continuously for at least 10 minutes)




Primary Outcome Measures :
  1. Change in muscle function [ Time Frame: 6 months ]
    Change in muscle function will be determined by the change in peak power achieved on the wingate anaerobic cycling test between the active supplement phase and the placebo phase


Secondary Outcome Measures :
  1. Change in muscle fatigue [ Time Frame: 6 months ]
    Change in muscle fatigue will be determined by the change in the fatigue index during the wingate test. Fatigue index is a percentage, and is calculated as follows: [(Peak Power - End Power)/Peak Power] x100

  2. Change in general fatigue [ Time Frame: 6 months ]
    Change in fatigue will be determined by the change in the Pediatric Quality of Life - Fatigue Module scores (PedsQL-Fatigue). This measure is scored on a scale of 0-100 with 100 representing the least amount of fatigue.

  3. Change in quality of life [ Time Frame: 6 months ]
    Change in quality of life will be determined by the change in the Quality of My Life questionnaire scores. Quality of my Life consists of 3 visual analog scales each scored out of 10. Higher scores indicate better quality of life.

  4. Change in physical function [ Time Frame: 6 months ]
    Change in physical function will be determined by the change in the hand grip strength, measured using a hand dynamometer. Three attempts will be given per hand, and the maximum grip strength achieved (in kg displaced) will be recorded for each hand.

  5. Change in physical function [ Time Frame: 6 months ]
    Change in physical function will be determined by the change in the vertical jump achieved, measured in centimeters



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Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages 7 to 18 years
  • Diagnosis of juvenile dermatomyositis (JDM) according to the 2017 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) criteria: ≥90% probability, age of onset <18 years
  • Subjects on a stable course of medication (unlikely to change over study treatment period as determined by treating physician)
  • Minimum height of 132.5cm (required to fit on the cycle ergometer)

Exclusion Criteria:

  • Subjects with newly diagnosed JDM within the previous 6 months
  • Subjects unable to cooperate with study procedures, or too weak to participate in the exercise testing
  • Subjects with impaired kidney function as determined from pre-baseline visit screening lab values (eGFR <90 ml/min/1.73m^2)
  • Subjects currently taking anti-hypertensive drugs or blood thinners
  • Subjects who are currently pregnant or planning to become pregnant within the study period

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04286178


Contacts
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Contact: Brian Feldman, MD, MSc 416-813-7707 brian.feldman@sickkids.ca
Contact: Saunya Dover, MSc 416-813-7712 saunya.dover@sickkids.ca

Locations
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Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Brian M Feldman, MD, MSc    416-813-7707    brian.feldman@sickkids.ca   
Contact: Saunya Dover, MSc    416-813-7712    saunya.dover@sickkids.ca   
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
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Principal Investigator: Brian Feldman, MD, MSc The Hospital for Sick Children
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Responsible Party: Brian Feldman, Division Head, Division of Rheumatology, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT04286178    
Other Study ID Numbers: 1000062314
HC6-24-c228771 ( Other Identifier: Health Canada )
First Posted: February 26, 2020    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myositis
Dermatomyositis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Polymyositis
Connective Tissue Diseases
Skin Diseases
Coenzyme Q10
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Vitamins